The Osia is a bone-conduction hearing system, which is a combination of two components:
sound processor (worn behind the ear).
surgically implanted piece under the skin behind the ear.
The piece implanted under the skin is attached to the bone of the skull. The external sound processor picks up sound and sends a signal to the internal device, which then vibrates the bone of the skull. The Osia conducts sound through the bone of the skull directly to the inner ear (cochlea) rather than through the middle ear which is a process known as direct bone conduction. No component of the Osia bone conduction system fits inside the ear or ear canal. The Osia has been approved by the Food and Drug Administration (FDA) as a class II device.
The Internal device consists of the titanium fixture that osseointegrates (i.e., grows into bone) with living tissue to form a permanent, functional bond with the bone of the skull. Titanium metal is unique in that bone will grow into titanium (this is why titanium is used for dental implants). During the surgical procedure, the internal device with the attached titanium fixture is placed in the mastoid bone behind the ear.
Who can benefit from an OSIA Bone Conduction Implant?
The Osia implant is approved for anyone over the age of 5 years old for the treatment of conductive or mixed hearing loss, as well as for unilateral, profound sensorineural hearing loss, also known as Single Sided Deafness (SSD).
Selection of the candidates is based on the criteria such as:
Congenital absence of the ear canal (microtia).
Chronic ear drainage from an outer or middle ear infection (since the Osia does not block the outer ear canal, as is true for hearing aids, which may be a cause for aggravation of chronic ear drainage).
Otosclerosis in an only hearing ear.
Any cause of conductive or mixed hearing loss .
Single-sided deafness, regardless of the cause of hearing loss.
The evolution of bone conduction technologies upgraded and resulted in the development of transcutaneous (non-skin penetrating) systems. Here, the skin remained intact and the external sound processor, with its vibrating actuator, was connected magnetically. Therefore, skin complications related to the abutment were eliminated.
The benefit is improved and maximized by proper candidate selection, magnet strength, and the use of a soft pad to distribute pressure across the magnetic connection area. The main drawback to these systems was a limitation in gain (especially in high frequencies) from attenuation of vibratory energy passing through hair, skin, and other soft tissues.
The transcutaneous bone conduction system, which utilizes an active electromagnetic implant coupled with an externally worn processor is developed, hence, to maintain the cosmetic benefits of magnetic coupling while improving output levels to overcome skin dampening. The Osia has been approved by the Food and Drug Administration (FDA) in 2018
An active osseointegrated device is introduced as an advanced technology, which consists of a surgically implanted titanium fixture that now supports a newly developed piezoelectric actuator.
The parts of the OSIA include,
That is placed under the skin.
The piezoelectric technology has been used in various forms for many years and is based on the unique property of certain materials whereby applied force or vibration generates an electrical current. This effect is reversed in the piezoelectric actuator in OSIA such that when an electrical current is applied, a mechanical change is rendered. Layers of the piezoelectric material bend; causing counterweights to generate and augment vibrations; and this vibrational energy is sent into the bone through the actuator’s connection with the implant.
The external sound processor houses a corresponding retention magnet, which keeps the sound processor in place and aligns the transmitting and receiving coils. This processor uses complementary technology developed for cochlear implants in the form of a digital link that transmits both power and digitally amplified signals to the internal receiver-stimulator package. The Osia 2 System was FDA approved in 2019 and is indicated for the treatment of single-sided deafness as well as mixed/conductive hearing losses.